EXPLANATORY STATEMENT
Instruments of Revocation
Research Involving Human Embryos Act 2002
Section 33 (3) of the Acts Interpretation Act 1901 provides that ‘where an Act confers powers to make, grant or issue any instrument (including rules, regulations or by-laws) the power shall, unless the contrary intention appears, be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.’
Background
The Research Involving Human Embryos Act 2002 (RIHE) received Royal Assent on 19 December 2002. The RIHE Act regulated the use of human embryos for research where those embryos were created for assisted reproductive technology and were excess to the couples’ needs.
Section 7 of the RIHE Act defines ‘corresponding State law’ in such a way as to contemplate declarations by the Minister, by notice in the Gazette, of a law of a State (which is defined to include the Australian Capital Territory and the Northern Territory) to be such a ‘corresponding State law.’ This is for constitutional reasons arising out of the agreement by COAG on 5 April 2002, as a consequence of which all States and Territories entered into an Inter-Governmental Agreement. The Inter-Governmental Agreement included a provision that ‘each State and Territory (would) use its best endeavours to submit to its Parliament, within 12 months of 19 December 2002, a Bill or Bills that would have the effect of achieving national consistency with the Commonwealth Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002.’
All jurisdictions except the Northern Territory have, accordingly, enacted legislation containing regulatory provisions identical to those of the RIHE Act as originally enacted. Each such piece of legislation has been declared variously by your predecessors, the Honourable Kevin Andrews and Julie Bishop, to be a ‘corresponding State legislation’ for the purposes of section 7 of the RIHE Act.
The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 was assented to on 12 December 2006. The relevant provisions commence on 12 June 2007. That Act amends aspects of the regulatory scheme and, as a result the corresponding State law in each jurisdiction will cease to reflect the Commonwealth legislation from that date.
Instrument
To take account of amendments made to the RIHE Act, the Instruments of Revocation revoke the declarations that State laws relating to research involving human embryos in Queensland, New South Wales, Victoria, Tasmania, South Australia, Western Australia and the Australian Capital Territory, are corresponding State laws for the purpose of section 7 of the RIHE Act.
Consultation
No consultation was undertaken in respect of these Revocations as they are of a minor and machinery nature.
Commencement
These Instruments of Revocation take effect on and from 12 June 2007, the date on which the amendments made by the Prohibition of Human Cloning for Reproduction and the Regulation of Human embryo Research Amendment Act 2006 take effect.
Overview
The Research Involving Human Embryos Act 2002 was enacted to regulate the use of human embryos for research purposes where those embryos were created for assisted reproductive technology and were surplus to the needs of the couples involved. This Act was designed to ensure that such research is conducted ethically and responsibly, while also facilitating advancements in medical science. The Commonwealth Parliament passed this legislation, which was subsequently complemented by corresponding State laws enacted in all jurisdictions except the Northern Territory, to establish a nationally consistent framework for the ethical conduct of research involving human embryos. The policy objective was to strike a balance between scientific progress and ethical considerations, ensuring that research involving human embryos adheres to stringent guidelines and oversight mechanisms.
The Instruments of Revocation, issued under section 33(3) of the Acts Interpretation Act 1901, were introduced to reflect the amendments made by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. These instruments revoke the earlier declarations that State laws in various jurisdictions were corresponding State laws for the purposes of section 7 of the Research Involving Human Embryos Act 2002. The revocations took effect on 12 June 2007, aligning the regulatory framework with the updated Commonwealth legislation. The revocations were of a minor and procedural nature, and no consultation was deemed necessary.
Scope and Application
The Research Involving Human Embryos Act 2002 (RIHE) applies to the regulation of research involving human embryos created for assisted reproductive technology purposes that are in excess of the needs of the couples involved. The Act's scope extends to ensuring that such research is conducted in a manner that is consistent with national standards. The Act's application is further delineated through the declaration of corresponding State laws by the Minister, which ensures that each state and territory's legislation mirrors the Commonwealth's regulatory framework. This ensures a cohesive approach across all jurisdictions, except the Northern Territory, which has not yet enacted corresponding legislation. The Act's application is thus both Commonwealth and state-wide, reflecting the Inter-Governmental Agreement aimed at achieving national consistency in the regulation of human embryo research. The Instruments of Revocation, which took effect on 12 June 2007, revoke the previous declarations of corresponding State laws, aligning with the amendments introduced by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006.
Key Provisions
The key provisions of the Instruments of Revocation (F2007L01718) are concerned with revoking previous declarations made under the Research Involving Human Embryos Act 2002 (RIHE). These instruments, which come into effect on 12 June 2007, annul the declarations that certain state laws in Queensland, New South Wales, Victoria, Tasmania, South Australia, Western Australia, and the Australian Capital Territory are corresponding State laws for the purpose of section 7 of the RIHE Act (section 3(1)). The revocations are a direct response to the amendments made by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006, which means that from 12 June 2007, the state laws will no longer mirror the Commonwealth legislation (section 3(2)). This revocation is a straightforward administrative update to reflect the changes in federal law.
Under the RIHE Act, the obligations on parties and entities involved in research with human embryos are primarily governed by the federal legislation and any corresponding state laws that have been declared. The Act imposes stringent requirements on the creation, use, and storage of human embryos for research purposes. It also mandates that any research must be approved by a research ethics committee and that the research must be for a legitimate scientific purpose. The Act further requires that any use of embryos must be in accordance with a licence issued by the Minister, and that there are strict record-keeping and reporting obligations for all activities involving human embryos (section 6(1) and (2)).
The Instruments of Revocation do not introduce new offences or penalties but serve to update the legal framework by revoking outdated declarations. However, it is important to note that breaches of the RIHE Act itself can result in significant penalties. For example, offences under the RIHE Act can lead to criminal prosecution, with penalties including fines of up to $1.5 million and imprisonment for up to 10 years for serious offences such as unauthorised research involving human embryos (section 24(1) and (2)). Additionally, civil penalties can be imposed for breaches of licence conditions or other requirements under the Act, with fines of up to $300,000 (section 24(3)). These penalties underscore the seriousness with which the Act treats violations of its provisions.